The Real Deal on Essure: What Moms Need to Know

by Sara Novak on September 28, 2015

Sara Novak

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Sara Novak is an independent journalist who specializes in public health, global health and food policy. Her work has been featured on Discovery Health, Planet Green, TreeHugger, HowStuffWorks.com, TLC, Animal Planet, Naturally Savvy, EcoSalon, and Zax Health.

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After years of thinking day-to-day about birth control, you're ready for something a little more permanent. And since you've decided to close the chapter on your childbearing years, birth control pills are becoming a daily nuisance and condoms lack spontaneity. For women in search of permanent birth control, Essure, which was approved by the U.S. Food and Drug Administration (FDA) 13 years ago, seems like the perfect option. An alternative to getting your tubes tied (also known as tubal ligation), it's a flexible, thin rod that's inserted into each fallopian tube. Unlike tubal ligation, it doesn't require general anesthesia and boasts a quick recovery. But this week, the FDA met with a panel of experts to discuss an onslaught of complaints ranging from severe to somewhat mysterious. The meeting left many women wondering whether Essure was still a viable birth control method, according to reports from The New York Times.

This week, the FDA heard testimony from the drug manufacturer, Bayer HealthCare Pharmaceuticals, regarding problems with the device. The day-long, public meeting also included spoken statements from women who claimed the device had caused a laundry list of health problems including severe pain, perforated fallopian tubes and autoimmune disorders.

The device, which consists of a tiny metal coil, works by causing an inflammatory response in the fallopian tubes, resulting in the growth of scar tissue. This scar tissue eventually blocks the fallopian tubes, preventing pregnancies. Doctors must first pinpoint where the coil will be inserted, then insert it through the vagina and 3 months later check whether the procedure has successfully blocked the fallopian tubes by inserting ink into the uterus and viewing it on an X-ray.

Many women may think they're protected after the coil is implanted, but full protection only comes once the scar tissue has formed -- and in some cases, it doesn't implant properly. Some patients complained of the coil ending up in their uterus, where -- although it's unlikely to do harm -- it wasn't protecting them from pregnancy. In fact, unplanned pregnancies are among the most common complaints from women, and with good reason. While the company claims that the device prevents pregnancy 99 percent of the time, that's only if the device is perfectly inserted and fully blocking the fallopian tubes. According to Dr. Aileen Gariepy, an assistant professor of family planning in the Department of Obstetrics, Gynecology and Reproductive Sciences at Yale School of Medicine, who was at the FDA meeting and has studied Essure extensively, in real terms, only 85 percent of women are fully protected from pregnancy after 3 months and 88 percent after six months.

"It's inherently a multi-step process, and it can take multiple attempts," says Dr. Gariepy. "Many women felt that they were not given the appropriate information prior to getting the procedure."

And beyond unplanned pregnancies, a number of other risks, though rare, may occur. Specifically, women with unknown metal allergies may be at risk of a negative reaction, so you may want to consider getting tested for a nickel allergy before considering the device. Additionally, perforation, or holes pierced in the uterus and fallopian tubes, are a rare risk in women who undergo the procedure. These risks were already listed on the Essure website.

But other women at the meeting complained of risks that prior to the device's approval were never studied -- namely autoimmune disorders. These conditions, including Celiac disease, lupus and Myasthenia gravis, mysteriously arose in women after they had the procedure. But according to Dr. Gariepy, autoimmune diseases have not been properly studied in conjunction with the device.

"We don't know enough about autoimmune diseases to begin with, and we especially don't know if they're somehow linked to Essure," says Dr. Gariepy. "It's not well studied and further investigation is definitely needed."

The concern is that inserting a foreign object into the body could cause the immune system to over react, causing various autoimmune disorders. However this kind of a reaction doesn't occur with heart stints and heart valves, for example.

What is know about autoimmune diseases is that women are already more likely be affected by them than men -- and this is especially true as they age. So it's unclear whether these disorders were in any way associated with the device in the first place.

Dr. Gariepy still recommends the device in some women, as long as they fully understand all of the risks. For some women, it's still the best choice, especially those who want permanent birth control but don't want to undergo the general anesthesia required of a tubal ligation. Indeed, The American College of Obstetricians and Gynecologists along with Physicians for Reproductive Health and Planned Parenthood Federation of America urged the FDA not to limit women who could benefit from getting the device based on anecdotal evidence.

"We are grateful to the Food and Drug Administration for hosting an important conversation about the safety of Essure and on the steps that the agency and the industry can take in order to ensure that Essure is used safely in the future. But we urge the FDA to recognize that restricting women's access to certain methods of birth control will limit their choices and, in some cases, expose them to additional risk." the organizations said in a joint statement.

What this means to you. Family planning is undoubtedly key to women who want to space out children for financial, career or relationship reasons. In fact, research has shown that women who don't wait at least 18 months after giving birth to conceive again are at an increased risk of preterm delivery. And when your childbearing years are complete, you may want more permanent birth control methods. Essure is indeed less invasive and as permanent as tubal ligation. But if you'd rather avoid any serious risk, you may want to consider intrauterine devices (IUDs), which last from five to 10 years. Talk to your health care provider about which choice is best for you. But whatever you choose, remember birth control is an essential part of women's health -- and the more choices, the better.

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